Johnson & Johnson (J&J) said it is closely monitoring day-to-day operations at its COVID-19 vaccine subcontractor Emergent BioSolutions after a production error at the company’s Baltimore, Md., plant contaminated up to 15 million doses. Read More

Pfizer and BioNTech have accrued the data necessary to submit a biologics license application (BLA) for their COVID-19 vaccine and are seeking full approval as soon as this month, following a recent analysis from their phase 3 trial showing the vaccine held 91.3 percent efficacy up to six months after the second dose. Read More

The European Medicines Agency (EMA) confirmed yesterday that it has not found any causal link between blood clots and inoculation with the AstraZeneca (AZ) COVID-19 vaccine. Read More

With Pfizer/BioNTech’s COVID-19 vaccine demonstrating 100 percent efficacy in patients aged 12 to 15 years in their phase 3 trial, the companies will seek an amendment to their Emergency Use Authorization (EUA) and other regulatory authorizations to allow its use in that age group. Read More

The FDA and the European Medicines Agency previously cautioned against using ivermectin as a COVID-19 treatment, as did Merck. Read More

Humanigen said it will seek an FDA Emergency Use Authorization for its monoclonal antibody lenzilumab “as soon as possible” based on positive results from a phase 3 clinical trial that showed the drug significantly reduced the risk of death for hospitalized COVID-19 patients. Read More

The Pfizer/BioNTech and Moderna vaccines are highly effective at preventing SARS-CoV-2 infections among healthcare and essential workers, a real-world study by the Centers for Disease Control and Prevention (CDC) has confirmed. Read More